Clinical trials: Delivery Systems
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
The study will evaluate the safety and efficacy of gene transfer therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study.
- Trial name
- EMBARK (NCT05096221)
- Testing
- delandistrogene moxeparvovec
- Where
- 42 sites in United States, Belgium and 7 more
- Volunteers
- 126 people
- Sponsor
- Sarepta Therapeutics, Inc.
Concussion, Brain, Concussion, Mild
Mobile Subthreshold Exercise Program for Concussion--R01
Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months.
- Conditions
- Concussion, Brain, Concussion, Mild, Brain Injuries, Traumatic, Persistent Post Traumatic Headache
- Trial name
- MSTEP-R01 (NCT04688255)
- Testing
- MSTEP, Stretching
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Seattle Children's Hospital
Hepatitis C, Chronic
Directly Observed Therapy for HCV in Chennai, India
The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting.
- Trial name
- C-DOT (NCT02541409)
- Testing
- Sofosbuvir, Pegylated Interferon alfa-2a, Ribavirin
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Diabetes Mellitus, Type 1
Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D
The goal of this study is compare the effect of hybrid closed loop system (HCL) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (T1D) in patient with different initial glycated hemoglobin.
- Trial name
- NCT05924932
- Testing
- Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6, MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
- Where
- Czechia
- Volunteers
- 120 people
- Sponsor
- Masaryk Hospital Usti nad Labem
Hantavirus Pulmonary Infection, Immunisation
Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03682107
- Testing
- Andes virus DNA vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
High Grade Glioma
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma…
- Trial name
- NCT05362409
- Testing
- 5 Aminolevulinic Acid, CV01-delivered ultrasound
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Alpheus Medical, Inc.
Stress Disorders, Posttraumatic, Depression
Re-Engineering Systems for the Primary Care Treatment for PTSD
The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD).
- Trial name
- RESPECT-PTSD (NCT00373698)
- Testing
- Three Component Model of Collaborative Care
- Where
- 4 sites in United States
- Volunteers
- 195 people
- Sponsor
- US Department of Veterans Affairs
Induction of Labour
REgistry of MisOprostol 200 µg Vaginal dElivery System
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included.
- Trial name
- REMOVE (NCT02242214)
- Testing
- Misoprostol
- Where
- Netherlands
- Volunteers
- 106 people
- Sponsor
- Ferring Pharmaceuticals
Abdominal Aortic Aneurysm (AAA)
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT02009644
- Testing
- Subjects who receive the Treovance stent-graft
- Where
- 29 sites in United States
- Volunteers
- 158 people
- Sponsor
- Bolton Medical
Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst
Hot AXIOS System Japan Post Market Survey
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
- Conditions
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis
- Trial name
- NCT03797209
- Testing
- EUS-guided fistulization AXIOS
- Where
- 40 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Boston Scientific Japan K.K.
Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with…
- Conditions
- Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction, Upper Limb Weakness Due to Tendon Transfer Surgery
- Trial name
- NCT06023316
- Testing
- mGain system
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Orthocare Innovations, LLC
Fibromyalgia
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia: a common problem that requires treatment Fibromyalgia (FM) is a highly prevalent pain syndrome characterized by generalized pain and fatigue, often leading to extensive somatic and psychological distress.
- Trial name
- NCT07054333
- Testing
- Internet-delivered exposure-based cognitive behavior therapy
- Where
- 2 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Karolinska Institutet
Zinc Deficiency, Diarrhea
Water-based Zinc Intervention Trial in Zinc Deficient Children
The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations…
- Trial name
- NCT01472211
- Testing
- zinc enriching filter (LifeStrawFamily), disinfection tablets
- Where
- Benin
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Swiss Federal Institute of Technology
Aortic Stenosis
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System.
- Trial name
- NCT02950428
- Testing
- ACURATE neo™TA Delivery System
- Where
- 7 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Symetis SA
Fetal Macrosomia, Gestational Diabetes
Regulation Of Maternal Fuel Supply And Neonatal Adiposity
The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.
- Trial name
- NCT00826904
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Health Problems in Pregnancy, Pregnancy Outcomes
Peking University Birth Cohort in Weifang (PKUBC-WF)
The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and…
- Conditions
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes, Gestational Hypertension
- Trial name
- NCT06234332
- Testing
- No Interventions
- Where
- China
- Volunteers
- 2,800 people, healthy volunteers welcome
- Sponsor
- Peking University
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Stroke, Acute, Cerebrovascular Disorders
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional…
- Trial name
- INTERACT4 (NCT03790800)
- Testing
- urapidil
- Where
- 4 sites in China
- Volunteers
- 2,425 people
- Sponsor
- The George Institute for Global Health, China
Epilepsy in Pregnancy
Pharmacokinetic and Placental Transfer of Levetiracetam
Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other hand.
- Trial name
- EPICEINTE (NCT04117425)
- Testing
- biological collection
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
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